Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Duration to achieve of full enteral feeds in days
研究概览
简要总结
Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and prevent excessive weight loss and dehydration. Availability of donor human milk (DHM) along with low incidence of necrotizing enterocolitis (NEC) in preterm infants born at 30-33 weeks have encouraged neonatologists to start feeding early and advance it faster in order to shorten time on parenteral nutrition (PN) and minimize the need for intravenous access. The objectives of this trial is to study whether exclusive enteral nutrition from day of birth (i.e. no PN) results in shorter time to achieve full enteral feed when compared with traditional feeding regimen that involves a combination of PN and progressive enteral feeding.
详细描述
Early nutritional support of preterm infants born at 30-33 weeks gestation is usually achieved via a combination of parenteral nutrition (PN) and enteral feeding that is advanced over few days to reach full enteral feed. Recent studies suggest that rapid increase of enteral feed volumes results in shorter duration on PN and earlier achievement of full enteral feed without increasing the risk of necrotizing enterocolitis (NEC) or death. Although PN has an important role in nutrition of preterm infants, it is associated with increased risk of metabolic and infectious complications even when it is used for a short period of time. Furthermore, PN mandates the need for peripheral or central intravenous access. Provision of full enteral feed volume that meets reference daily fluid intake from day of birth is used frequently and successfully in stable preterm infants born after 33 weeks. Expanding the use of this regimen to stable preterm infants born at 30-33 weeks gestation may help avoid unnecessary start of intravenous access, prevent complications related to PN, and encourage mother-infant bonding experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
- •Birth weight greater than 1000 g
- •Consent to use donor human milk
- •Postnatal age is less than 48 hours from birth
- •Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).
排除标准
- •Cord PH < 7.00 or Cord base access (BE) < -16
- •Apgar score < 7 at 5 minute
- •Lactate level ≥3 (if done for clinical indication)
- •Need for positive pressure ventilation (PPV) for >1 minute.
- •Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)
- •Small for gestational age <3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.
- •Major congenital malformation
- •Symptomatic or severe hypoglycemia (blood glucose <1.8 mmol/L)
- •Infants with moderate to severe respiratory distress.
结局指标
主要结局
Duration to achieve of full enteral feeds in days
时间窗: Till 30 days of life
Day of life to achieve full enteral feeding defined as 140 ml/kg/day which is sustained for at least 3 days
次要结局
- Length of hospital stay(At discharge from neonatal intensive care unit (NICU), up to 90 days of life)
- Incidence of late onset sepsis(At discharge from NICU, up to 90 days of life)
- Incidence of hypoglycemia(Till 30 days of life)
- Feeding intolerance(Till 30 days of life)
- Incidence of NEC(At discharge from NICU, up to 90 days of life)
研究者
Belal Alshaikh
Neonatologist
University of Calgary